MAUDE Adverse Event Report: ETHICON INC. SFX SYM PDS+ VIO 18IN 2-0 S/A CT-2; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	SXPP1A408
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested and the following was obtained: did any piece of the needle fall inside of the patient? => no, it didn't.If so, was the needle piece removed and how? => n/a.No further information will be provided.".
Event or Problem Description
It was reported that a patient underwent an unknown chest/ thoracic procedure on unknown date and suture was used.The suture was detached from the needle during continuous suturing.It was not a control release needle.The surgeon¿s way of suturing was as usual.The suture in question was intentionally cut to be released from the tissue.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Product complaint #: (b)(4).A detached needle, a dispensed suture in two sections and one labeled empty winding former was returned for analysis.During the visual inspection of the needle the swage and attachment area were as expected.The barrel hole of the needle was examined under magnification and no suture remnant was noted.The suture was examined and the insertion end was measured and did not meet the requirement.The manufacturing records couldn¿t be reviewed as the batch number is unknown.Per the sample condition, the assignable cause of the performance - damaged product is a short insertion.This defect is caused because the insertion of the suture in the needle was insufficient from keep the needle/suture union during transportation or use, the reported complaint was confirmed.

• Brand Name: SFX SYM PDS+ VIO 18IN 2-0 S/A CT-2
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7440327
• Report Number: 2210968-2018-72171
• Device Sequence Number: 19119240
• Product Code: NEW
• UDI-Device Identifier: 10705031219335
• UDI-Public: 10705031219335
• Combination Product (Y/N): N
• PMA/510(K) Number: K113004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: SXPP1A408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Initial Date Received by Manufacturer: 03/26/2018
• Supplement Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 04/18/2018
• Supplement Report FDA Received Date: 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1